CAPITAL MARKETS DAY CREATING VALUE FOR INVESTORS THROUGH NEXT PHASE OF GROWTH
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CREATING VALUE FOR INVESTORS
THROUGH NEXT PHASE OF GROWTH
CAPITAL MARKETS DAY
NOVEMBER 2021
DISCLAIMER
This Presentation has been prepared by Laboratorios Farmacéuticos ROVI, S.A. (the “Company”) and comprises the slides for a presentation concerning the Company and its subsidiaries (the “Group”). For the
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2
AGENDA
Hour AGENDA
Update on ROVI’s strategy
10:00 am Juan López-Belmonte, Chairman and CEO
Update on R&D strategy
10:30 am Ibón Gutierro, R&D Manager
Financial results
10:50 am Javier López-Belmonte, Vicepresident and CFO
11:00 am Q&A
Closure
11:30 am Juan López Belmonte, Chairman and CEO
Chair: Marta Campos, Head of Investor Relations
3
Update on ROVI’s strategy Juan López-Belmonte Chairman and Chief Executive Officer
OVERVIEW
MKT CAP (€M)1 Solid specialty pharma growth story coupled Revenue
Madrid, with strong potential from the ISM® Platform 9M 20212
Spain +7.5x
Company HQ 4.000 3,544
3.500 Leading • Unparalleled know-how of the Low Molecular Weight Heparin
(“LMWH”) market.
Proprietary
3.000
LMWH
38%5
2.500 • 2 in-house developed flagship products: Bemiparin Hibor®
2.000
Franchise (“Hibor®”) and Enoxaparin biosimilar Becat® (“Becat®”)
1,419 1.500 • Through its large and specialized sales force (c. 250 employees)
Employees 1.000
Leading Spanish
ROVI distributes in Spain its proprietary products and third party
as of Dec 500
473 Specialty products through in-license agreements 23%6
Pharma
2020 0 Business • 14 new in-licensed products over the last 12 years
Market Cap (Mn€)
Dec 2007-IPO Current • Vertical integration and fully-invested production facilities allow
ROVI to offer high-value-added injectable and oral forms CMO
c.250 TOTAL REVENUES (€M)2 CMO services 39%7
Specialty • One of the global leaders in pre-filled syringes manufacturing3
Pharma Sales
Force CAGR: 12%
700 +40%-45% • Patent-protected, long-acting sustained-release injectable
600 technology provides versatile platform with wide applicability
500 across multiple drug candidates
400 ISM®4 • Lead candidate Risperidone ISM®, a long acting
6 300 Technology injectable of risperidone for schizophrenia. Application for In regulatory process in
200 119 marketing authorisation filed in Europe in Jan 2020 and in
Fully Invested Platform Europe and United Estates
Manufacturing 100 USA in Nov 2020
Facilities 0 Currently in Clinical
Total Revenues • A long-acting injectable of Letrozole for hormone-
(Mn€) dependent breast cancer is currently in Phase I Development Stage
Dec 2007-IPO 2021E
1. CapIQ as of Nov 3, 2021.
2. Total revenues include sales from products and services, royalties and government grants. 5. Includes revenues from Hibor®and Becat®.
3. In terms of annual number of units manufactured. Offers filling and finishing; does not manufacture the syringe itself. 6. Includes sales of goods excluding Hibor® and Becat®. 5
4. ISM® stands for “In-Situ Microimplants” technology. 7. Includes sales of services.
ROVI Under Transformation
ROVI ROVI
today Next Steps in the future
Leading Proprietary Presence in more than 70 + New enoxaparin Potential presence in
Heparin Franchise countries biosimilar launches more than 120 countries
Leading Spanish c. 250 specialty pharma + Specialized Psychiatric Specialized psychiatric
Specialty Pharma sales force salesforce in Europe salesforce in Europe
Business
+ Second API LMWH plant
in Granada 8 fully invested
CMO 6 fully invested manufacturing facilities
+ Risperidone and
manufacturing facilities Manufacturing partner for
Letrozole plants
Moderna outside USA
+ Moderna agreement
+ Risperidone ISM® + At least 5 key own products
ISM® Technology 2 key own products (Bemiparin + Enoxaparin
Platform Letrozole ISM® +
(Bemiparin and biosimilar + Risperidone ISM®
Risperidone ISM® + Letrozole ISM® +
Enoxaparin biosimilar)
(quarterly) Risperidone ISM® (quarterly)
6
Proven Track Record in Creating Value for Shareholders
Management team has created value for ROVI share Price vs Eurostoxx50 and Ibex-35
shareholders (Base 100)
200
Increased sales by 53% and EBITDA by 100% in 9M 2021 180
160 +50%
140
Successfully launched enoxaparin biosimilar Becat® in 10 +22%
new countries and signed agreements in 12 new countries in 120
the last 12 months 100
80
+13%
Increased enoxaparin sales by 17% in 9M 2021 60
40
20
Risperidone ISM® in approval process in Europe and USA 0
Extension of the collaboration with Moderna Rovi Eurostoxx 50 Ibex 35
Source: Investig,com
7
ROVI improves its ESG Rating in 2021
2nd position out of 432 companies
(in the sub-industry “pharmaceuticals”)
Rovi has obtained an
ESG Rating 2021 of 2.309 out of
13.573 Global Universe
18,4
(low risk between 10 and 20)
17 out of
896 Industry Group
(biotech + laboratory equipment +
pharma companies)
2 out of
432
Subindustry
(pharma companies)
8
Key Company Highlights
Well-balanced pan-European specialty pharma business with diversified
growth drivers
Unparalleled proprietary heparin franchise with strong European footprint
Leading Spanish specialty pharma franchise
High-value-added global CMO business with differentiated capabilities
Proprietary ISM® Platform opens up new avenues of growth
Ownership of technology and vertical integration enhance competitive
position
Potential wide applicability of ISM® technology to new chronic therapeutic
areas
Sound financial policy supported by strong track record
9
Well-Balanced European Specialty Pharma Company with
Three Diversified Growth Drivers
Leading Proprietary Leading Spanish Specialty High-Value-Added CMO
LMWH Franchise Pharma Franchise Services
• Developed and successfully launched • Strong market leadership in Spain • One of the global leaders in pre-filled
proprietary LMWH bemiparin, the 2nd 1 injectables manufacturing
leading LMWH in Spain • Partner of choice for in-licensing for
leading global players • Fully-invested production facilities
• Developed enoxaparin biosimilar, one of the
first to reach the market • Highly skilled c.250 person sales force • Help absorb fixed costs and overheads,
providing for highly cost-competitive
• Vertically integrated, well positioned to manufacturing position
benefit from significant economies of scale
• Particularly strengthens the LMWH franchise
which relies on ROVI’s production capabilities
GROWTH DRIVERS
• Continue gaining branded LMWH market • Leverage on leadership position in • Drive volume growth from existing
share through bemiparin and enoxaparin Spain customers
biosimilar in Spain and abroad
• Maintain strong sales performance • Additional CMO customers given
• Launch enoxaparin biosimilar across and operational excellence strong economies of scale
more European countries and other
international markets • New in-licensing opportunities with • Agreement with Moderna
global players in specialty
• Roll-out of pan-European commercial therapeutic areas
network
• Second active principle heparin plant in
Granada which will allow ROVI to double
its capacity
1. IQVIA MIDAS Sept. 2021 10The LMWH market has increased by 3% over the last 3 years (in units)
800
Market growth – Million units Market growth Market size
721
Enoxaparin is the main The size of the market is
665
645
700
driver with an average over €4Bn where EMA-
600
growth of 5.7% in Q1 2018- ROW represent 83% of
Q1 2020 MAT to 721Mn the market
500 units in Q1 2020 MAT
400
300
200
Enoxaparin means
107
106
103
83
79
63% of the market
74
66
58
61
100
34
35
32
26
26
26
18
19
(€2.6Bn)
15
0
ENOXAPARIN NADROPARIN DALTEPARIN TINZAPARIN BEMIPARIN CERTOPARIN PARNAPARIN
SODIUM CALCIUM SODIUM SODIUM SODIUM
MAT Q1 2018 - SU (M) MAT Q1 2019 - SU (M) MAT Q1 2020 - SU (M)
REGION (€Mn) ENOXAPARIN NADROPARIN DALTEPARIN TINZAPARIN BEMIPARIN OTHERS TOTAL
SODIUM CALCIUM SODIUM SODIUM
EMA 1,323.3 173.3 145.8 297.5 107.9 62.6 2,110.4
RoW 687.3 176.3 73.7 16.3 23.7 297 1,274.2
USA-CAN 547.5 0.0 68.5 22.0 0.0 0.0 637.9
Japan 8.5 0.0 13.2 0.0 0.0 11.1 32.8
Total 2,566.5 349.7 301.2 335.8 131.6 370.6 4,055.3
Source: IQVIA MIDAS Q1 2020 11Bemiparin Hibor® is ROVI’s First Internally-Developed Flagship
Heparin Product
Unparalleled Know-How of the Heparin Market Bemiparin HIBOR® is the LMWH with the
highest anti Xa/IIa ratio, which may lead to
a higher antithrombotic activity without
• ROVI has been engaged in the development of heparin-based drugs for over 70 years increasing the bleeding risk
• Bemiparin Hibor® is a Low Molecular Weight Heparin (LMWH)
#2 market position in Spain with a c.32% 1 market share and marketed in 59 countries in More convenient treatment: 1 daily
total injection needed in comparison to Sanofi’s
Only 2nd generation LMWH; clinically differentiated from other competitor (such as (Clexane / Lovenox) treatment
Sanofi’s Clexane / Lovenox) (which needs 2) 2
• Vertically integrated structure with its own LMWH manufacturing plant
Established international network
Bemiparin Hibor® Global Sales supported by long-term contracts with
leading local pharma distributors
+7%
120
+13%
101
97
91 Marketed in
100 84 86 In-house legal team with regulatory know-
76 59 countries
80 24 27 33 how has achieved marketing
€m
25 34 authorisations worldwide
60 26
Pending registration in
67 70 68 13 countries
40 59 50 52
20 International Bemiparin sales in ROVI are
2017A 2018A 2019A 2020A 9M 2020 9M 2021 expected to decrease due to our focus on
Spain International the enoxaparin biosimilar outside Spain
1. Iqvia Midas Sep 2021
12
2. Bemiparin, thanks to its superior pharmacological profile, is the only second-generation LMWH that guarantees an effective 24h coverage with an always once-daily dose in all patients' profiles, regardless of their risk level.Enoxaparin €2.6bn Global Market Represents an Untapped Opportunity to Be
Explored with ROVI’s biosimilar Becat®
European Market Represents an Attractive Well-Positioned for Long-Term Leadership
Opportunity in LMWH
• ROVI aims to become one of Europe’s top players in a €1.3bn
• Enoxaparin (such as Clexane / Lovenox) is the world leading LMWH
market
• Europe is the largest Enoxaparin market worldwide (>50%)1
• ROVI’s competitive advantages within the LMWH market:
€2.6bn +5.7% €1.3bn
721m Global €0.7bn
Global European Emerging
units Q1 18- Q1 20
Sales1 Sales1
Global Sales1 Markets Sales1
MAT CAGR1
European Uncrowded Competitive Landscape
Originator
• Originator product developed by Sanofi Aventis
• Patent expired in 2011 (high entry barriers: first biosimilar
entered the market 6 years after patent expiry)
• ROVI markets its internally-developed enoxaparin
Biosimilar
Enoxaparin
biosimilar
biosimilar
Becat® • Launched in Sep’17 with total sales of €101.4Mn in 2020 and
€89.9Mn in 9M 2021
In the long term, biosimilars tend to reach a 50%-70% share
of the reference product market2
1. IQVIA MIDAS Q1 2020 13
2. Technavio 2016 biosimilars reportStrong growth potential of Enoxaparin Biosimilar Becat®
Well-Established Network to Minimize Time-
Stage I of Commercial Strategy
to-Market
ROVI will directly market In the long-term,
enoxaparin biosimilar Becat® biosimilars tend to reach
Direct in 7 European countries… a…
Approved in
Marketed in 26 countries Launched
Germany, UK, in Europe and in 4
Italy, Spain, 24 in the Rest 50-70%
28 countries
Portugal and of the World Market Share
Poland
…which account for
…the largest
Enoxaparin Biosimilar Becat® Sales Ramp-up enoxaparin market
2 c.75% 3 …of the reference
of the European product market
with €1.3bn sales
market
+17%
40
35
33,3 Launches in 9M 2021
29,6 29,4
28,0 27,2 27,2
30 24,8
25 20,0 19,8 ROVI launched enoxaparin in Canada, Malasya, Albania, North Macedonia,
20 16,5 16.4
13,5 Guatemala, El Salvador, Honduras, Georgia and Bahamas.
15
7,8
10
4,1 4,8
5 1,5
0 1
1. Becat® 4Q 2017 sales include sales throughout September. As the product was launched that month, sales 3. QuintilesIMS, 2015. 14
were negligible. 4. Technavio 2016 biosimilars report.
2. IQVIA MIDAS Q1 2020International Growth Potential of Enoxaparin Biosimilar Becat®
Stage II of Commercial Strategy Agreements with International Partners
Continue international expansion in other markets with
strong growth potential through out-licensing
€0.7bn
agreements Q1 2020 MAT
Already Signed Out-Licensed Agreements: 107 Market Sales1
Countries
ROVI signed a licensing agreement with Sandoz to
distribute enoxaparin biosimilar Becat® in 14
countries/regions and with Hikma in 17 Middle East and
North African countries.I
20222 20232
• Brazil • Mexico
• Colombia • Montenegro
• Serbia • Sri Lanka
• Bosnia • Ecuador
• New Zeland • Argentina
• Kosovo • Vietnam
• Lebanon
• Jordan
• Irak
1. IQVIA MIDAS Q1 2020
15
2. Most important markets to be launchedROVI aims to become one of the leaders in the LMWH market
Enoxaparin biosimilar penetration in the retail ROVI vs competitors: Spanish value market (%)
market (%)
• Global market of enoxaparin (units) grew 8.3% in MAT Q1 20201
Hibor® close to surpass Clexane in September 2021
• EMA2 reached a 21.1% penetration rate (MAT Q1 2020), growing from 7.2% in
MAT Q1 2019
• In Q1 2020, this EMA2 penetration rate has accelerated to 26.3%
30% 26%
21%
20%
10% 7%
0%
MAT Q1 2019 MAT Q1 2020 Q1 2020
ROVI vs competitors: European retail market
in units (%)
23% 57%
20%
Q1 20202
Italfarmaco Techdow ROVI
1. Iqvia Midas 16
2. Iqvia Midas: Europe. Sales exclude Poland as Techdow enoxaparin biosimilar was launched through a different dossierSpanish Market Leadership Positions ROVI as the Partner of Choice for Global
Pharma Players in Spain
Our Strong Market Leadership in Spain… …allows us to be the Partner of Choice for Global Pharma Players in Spain
Servier
Presence in the Spanish market 2007
since 1946 Merck
2008
Well-known proprietary portfolio Broad portfolio of innovative products
driving strong leadership position 2009
Ebewe Pharma Servier
2010
Franchise focused business: 20
proprietary and 28 in-licensed Merck Proven track record with 14 new
products
2011 products in the last 12 years
2012
Multiple Strategic Alliances Medice Familiar with national regulatory
2013 phases, pricing and product
Novartis reimbursement schemes
2014
Astellas Merck
Lengthy track record in strategic
2015 agreements, having an attractive
Novartis
portfolio of long-term contracts
2016
Orexygen
One of the largest specialty pharma
sales forces in Spain with c.250
2017
Astellas Indivior Europe Long patent-protected portfolio
employees Pharma S.A1 Limited 1
2019
Pegasys® Eufilina® 1
Strong knowledge of the Spanish 1 1
Vifor Pharma
regulatory framework Pharmaand AstraZeneca 2021
1. Co-promotion products 17High-Value-Added Global CMO Services
CMO Targets
Customer-oriented business model
Toll manufacturing sales
High-value-added service with pre-filled increased 39% in 2020 and 187%
syringes toll manufacturing
in 9M 2021
Differentiated capabilities drive significant
barriers to entry • ROVI expects the CMO
business to increase by
between 2 and 2.5 times,
Revenue visibility on the back of long-term including production of the
agreements
COVID-19 vaccine.
International sales represent c.97% of CMO • ROVI aims to become a long-
business
term manufacturing partner for
Moderna
Clean regulatory track record at
manufacturing plants with multiple GMP /
FDA approvals
18ROVI strengthens its collaboration with Moderna (1/2)
Fill-Finish manufacturing
• Investment in 2 new lines for compounding, filling, automatic
visual inspection and labeling at ROVI’s San Sebastián de los
Reyes (Madrid) facility
• These lines will more than double the number of vials for which
there is fill-finish capacity at this facility
• Supply to markets outside the United States
DARA 2
• Expected to come into operation in Q4 2021
DARA 3
• Expected to come into operation between Q2 and Q3 2022
19ROVI strengthens its collaboration with Moderna (2/2)
Manufacture of the active substance
• Installation of a new line in Granada
• Production capacity equivalent to more than 100
million doses per year
• Greater vertical integration of the vaccine production
process
• Supply to markets outside the United States
20Update on the R&D strategy Ibón Gutierro R&D Manager
ISM® Platform opens up new avenues of growth for ROVI
Overview
• Internally-developed and patented innovative drug-release technology, ISM®, Key Company Highlights of ISM® Platform
1
which allows for the sustained release of compounds administered by injection
2
Pop PK model & Expected high
• Based on two separate syringes respectively containing (a) the drug and polymer
simulations already success rate in Phase
(solid state) and (b) the solvent (liquid state)
1 Predictability validated for III in new
Risperidone ISM® in developments
• Potential wide applicability of ISM® technology to new chronic therapeutic areas,
Clinical Program
including psychiatry and oncology
• 505(b)(2) path of approval for candidates leveraging ISM® technology 2 Usability Improved stability No cold chain needed
Potential Selecting the most
Product Current Situation Key Milestones
Indication convenient posology From 1 to 6-month
Key 3 Flexibility
Milestones depending on clinical administration
In approval
Risperidone ISM® needs
Phase III process
Risperidone, Schizophrenia
in Europe and
monthly
in USA Long-acting injection
Improved Rapid onset &
(1-6 months) plasma
Letrozole ISM® Phase I started 4 Clinical sustained clinical
Breast Cancer Phase I therapeutic levels effect
Long acting in November Management from day 1
Letrozole 2017
Risperidone, Technological barriers
Schizophrenia Non-Clinical (e.g. power filling)
quarterly Protected technology
Vertical
5 Strong IP Fully integrated
Integration Manufacturing manufacturing plants
Concentrated on improving posology for already approved compounds, which
benefits risk / reward profile capabilities
Multiple FDA / GMP approved facilities to support the platform
1. ISM® stands for In Situ Microimplants®. 22
2. PK stands for pharmacokinetic.Risperidone ISM®: Attractive Schizophrenia Market with Strong Growth Prospects
Attractive Schizophrenia Market Solid Grounds for Success for a Risperidone LAI
● Chronic and progressive disease High treatment switching rate
● Affects 21m people worldwide with a relatively high lifetime prevalence1 LAI schizophrenia
● Strict compliance needed to avoid relapses market presents
● LAIs2 are becoming the gold standard for treatment given improved Focused group of psychiatrists to target
key features for a
adherence and effectiveness
successful launch Increasing penetration of LAIs across
MAT Q3-19 Schizophrenia Market Value US & EU3 treatment paradigm
Ample Market with Room for New Entrants: Alkermes Success
Story 5
Aristada® Net Sales
282
300 241
250 189
200 148
150 94
● Largest schizophrenia LAIs ● Second largest schizophrenia LAIs
100
market market
● MAT Q3 2015 – MAT Q3 2019 CAGR ● MAT Q3 2015 – MAT Q3 2019 CAGR of 8.5% 50
of 20.0% ● Relatively low competition due to fewer
0
● Higher prices than other markets drug options
2017 2018 2019 2020 2021E
● LAIs penetration: 5.8% (in monthly ● LAIs penetration: 8.4% (in monthly
treatments)4 treatments)4
Due to current low penetration, schizophrenia LAIs sales are expected to drive future market growth
1. Epidemiology data-Kantar Health Epi Database®.
2. LAIs stands for Long Acting Injectables. 4. Iqvia Midas MAT Q3 2019 and Rovi’s monthly treatments estimates. 23
3. Iqvia Midas MAT Q3 2019. 5. Alkermes results.LAIs are becoming the gold standard for treatment in EU5
• LAIs market grew by 9% from Q3 2017 (MAT) to Q3 2019 (MAT) in EU5
• Spain is the biggest market, representing 23% of European sales, and grew by 7% in the period Q3 2017-Q3 2019 (MAT)
• LAIs represent 57%1 of the Spanish antipsychotic market
• Risperidone is the second preferred molecule in EMA and USA
Antipsychotic LAIs sales – EU5 (€Mn) Schizophrenia market (Standard units MAT
Q3 2019)
+7% +9% +6% +16% +7% 500 438
350
301 400
300
260 271 289
300
250 222
187 199 195 175
€ millions
200 174 180 200 157
133
150 88 74 94 105
150 131 100 74
112 24 36 37
- 9 7
100 0
53 56 61
50
0
SPAIN GERMANY FRANCE ITALY UK
MAT Q3 2017 MAT Q3 2018 MAT Q3 2019 EMA USA-CAN
1. Source: IQVIA Midas MAT Q3 2019 24Risperidone ISM®: Fast Onset Long-Acting Injectable of Risperidone
Superior Value Proposition When Strong Product Expected to Offer Superior
Compared to Alternatives Characteristics
• Ongoing monitoring of non-
Fully adherence through regular INVEGA INVEGA
supervised interactions between patient and RISPERDAL SUSTENNA®/ TRINZA® / ABILIFY ARISTADA® PERSERIS® Risperidone
medical staff CONSTA® XEPLION® TREVICTA® MAINTENA® (Aripiprazole (Risperidone ISM®
monthly (Risperidone) (Paliperidone) (Paliperidone) (Aripiprazole) Lauroxil) Atrigel®) (Risperidone)
injection
• Reduce the risk of accidental or
Once Monthly
deliberate overdose Administration 4 Quarterly 12-14
• Proven efficacy and safety of
No Oral After >4 months
Clinical Risperidone1 Supplementation / Inv. Sustenna/ 12-14
Convenience Loading dose 4 Xeplion
of Risperidone • Well-known drug among psychiatrists
for the treatment of schizophrenia
Therapeutic Levels2
within First 2 12,13
• Fast onset of action to achieve Hours 4
Therapeutic therapeutic plasma levels from the
plasma levels beginning Currently Marketed in
from Europe 5, 6 Targeted
2 hours post • Achieving significant PANSS3
dose aimed at reduction in unstable schizophrenia Stability at Room
PANSS patients at day 8 Temperature 4
reduction at
day 8 • No need to supplement with oral PANSS Reduction
medication or loading dose from Day 815 7 8 4 9 10 11 14
1. Leucht et al. Am J Psychiatry 2017. 7.Kane et al. Am J Psychiatry 2003
2.The therapeutic concentration range of risperidone is quite wide and can vary from 10 ng/mL to 80 ng/mL or even higher (Remington et al. Am J Psychiatry 2006). 8.Pandina et al. J Clin Psycopharmacol 2010.
3.PANSS: positive and negative syndrome scale. Scale used to evaluate the symptoms of patients with schizophrenia. 9.Kane J et al. J Clin Psychiatry 2014.
4.Drugs@FDA:FDA Approved Drug Product. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm 10.Meltzer H et al. J Clin Psychiatry 2015.
5.Only applies to Risperidal Consta: Heads of Medicines Agencies. MRI Product Index. Available at: http://mri.cts-mrp.eu/Human/ 11.Nasser A et al. J Clin Psycopharmacol 2016.
6.European Medicines Agency. European Public Assessment Reports. Available at https://www.ema.europa.eu/en/medicines 12.Llaudó J et al. Int Clin Psychopharmacol 2016
13.Anta L et al. Int Clin Psychopharmacol 2018
14.Correll et al. NPJ Schizophrenia 2020
15.Statistically significant PANSS total score reduction versus placebo in acutely exacerbated schizophrenia patients after the first 25
injection of the long-acting antipsychotic without oral antipsychotic supplementation and/or loading doseEuropean regulatory process - Where are we?
Resume of regulatory process
Day 1 Day 120 Day 180
Secondary
Primary evaluation evaluation
Validation
(List of questions) (list of outstanding
issues)
Responses
We are here
Day 181 – 16/11/2021 Day 210 Day 237
Resume of the CHMP1 Positive Transmission to
process Opinion (For DE) Commission
Responses
Day 261 Day 277- 21/02/2022
• Successful repetition of the clinical bioavailability trial
using the oral risperidone medicine marketed in
End of “Standing
EC Approval-End of Europe
Commission
Procedure • Information to be submitted today to EMA
Consultation”
• Positive opinion expected in 30 days or at the next
CHMP1 meeting scheduled by end of February 2022
1 Committee for Medicinal Products for Human Use 26Therapeutic Indication – Covering the Unmet Medical Need (1/2)
Requested Therapeutic Indication to EMA Treatment of Schizophrenia in adults
Risperidone ISM® would be the ONLY1 Long-Acting Injectable Antipsychotic that can be
administered to unstable patients with severe or moderate psychotic symptoms suffering a relapse
• Dynamic market originating in hospitals
• In Germany and UK, around 72% of
prescriptions in hospitals correspond to
Dynamic market for patients who start treatment with a LAI2
LAIs2 (new treatment
and changes) • Competitive advantage because of the
represents ~72%3 of potential unique indication of Risperidone
total market ISM®
1 In the European Union 3 Source: IQVIA 27
2 LAI: Long-Acting InjectableTherapeutic Indication – Covering the Unmet Medical Need (2/2)
Risperidone ISM® has a unique Pharmacokinetic profile making the product suitable to treat stable
schizophrenia patients as well as unstable schizophrenia patients requiring a fast onset of action
ACHIEVES FAST NO LOADING DOSE/ORAL SUSTAINED THERAPEUTIC
THERAPEUTIC PLASMA SUPPLEMENTATION LEVELS ALLOWING A ONCE
LEVELS2,3 NEEDED1-3 MONTHLY POSOLOGY1-3
PRISMA-3: RISPERIDONE ISM® DEMONSTRATED
EFFICACY IN SEVERE PATIENTS AS EARLY AS DAY 81
1. Correll CU, et al. Efficacy and safety of once-monthly Risperidone ISM® in schizophrenic patients with an acute exacerbation. NPJ Schizophr. 2020 Nov 25;6(1):37
2. Anta L, Llaudó J, Ayani I, Martínez J, Litman RE, Gutierro I. A phase II study to evaluate the pharmacokinetics, safety, and tolerability of Risperidone ISM multiple intramuscular injections once every 4 weeks in patients with schizophrenia. Int Clin
Psychopharmacol. 2018 Mar;33(2):79-87.
3. Llaudó J, Anta L, Ayani I, Martínez J, Schronen J, Morozova M, Ivanov M, Gutierro I. Phase I, open-label, randomized, parallel study to evaluate the pharmacokinetics, safety, and tolerability of one intramuscular injection of risperidone ISM at different dose 28
strengths in patients with schizophrenia or schizoaffective disorder (PRISMA-1). Int Clin Psychopharmacol. 2016 Nov;31(6):323-31.USA regulatory process – Where are we?
The recommended follow-up
phases with the FDA1 were On 24 September, 2021, ROVI
covered: received a Complete Response
ROVI submitted the dossier to the
• Pre-IND2 FDA1 on November 24, 2020 Letter from the FDA with
• IND2 outstanding questions on the
• End of phase II Risperidone ISM® dossier
The indication
• Pre-submission meeting
pursued in the
US is the same
as all other LAIs3
have,
"Treatment of
schizophrenia in
The FDA will be taking a number of adults"
The Company has either answered
actions, including an in-situ
them or will be answering them in
inspection of the European Marketing authorization expected
the near future. ROVI expects its
production plant where the to be granted in Q3 2022
responses to clarify the
product is manufactured, located
outstanding questions
in Madrid (Spain)
1. FDA: Food and Drugs Administration 3. LAI: Long.-Acting Injectable 29
2. IND: Investigational New DrugNew Risperidone ISM® brands
Risperidone ISM® trademark has changed because of a trademark conflict. New trademarks are:
Okedi®
Risvan ®
30Risperidone ISM®: International Distribution Plan
• Existing pan-European infrastructure leverageable for
Top EU 5 +
Austria and further growth of Risperidone ISM®
Portugal (EU
7) directly • Local offices in Top 7 European countries where ROVI has
marketed by
ROVI presence
Ditribution • ROVI is already preparing the launch of the product in
Plan Germany
• 25 employees in our German subsidiary
Rest through
domestic or
international
players
2023
Q1 2023 Rest of EU7
Q4 2022 Italy
Q3 2022 Spain
Q2 2022 United • In US, distribution might be through partners
Kingdom
Germany • RoW the product will be marketed through partners
31Small Salesforce needed to address the psychiatric community
For 2nd gen LAIs, prescribers are fairly concentrated with ~10% contributing to 60% of
total volume
2nd generation LAIs-Prescriber concentration
In United States, 7,000 prescribers
account for 80% of the 2nd generation LAI
treatment volume.
Small Salesforce to be needed to
address the psychiatric community
Source: IQVIA
Source: IQVIA
32Letrozole ISM®: Second ISM® Candidate in Phase I Trial
Overview Preliminary Phase I Results
Hormone receptor-targeting drugs offer a unique opportunity to leverage ISM® technology.
Aromatase Inhibitors (AI) Letrozole and Anastrozole are used in HR+ breast cancer as they Rapid and sustained estrogen suppression with lower doses
block the production of estrogen in post-menopausal women. 6
5
• Oral Letrozole is the gold standard treatment for HR+ breast cancer E2 suppression – Competitor Oral
E2 Plasma Levels
4
E2 suppression Letrozole ISM®
• Current posology of AIs is daily oral – potential for Letrozole ISM® targeting a long-acting
(pg/mL)
3
injection to meaningfully disrupt the market and improve patient outcomes
2
• Currently, there is no LAI approved for Letrozole in the market Time (days)
1
Upcoming Key Catalyst: 0
0 4 8 12 16 20 24 28 32
• The company has initiated discussions with the FDA to review Letrozole ISM® Phase I
results as well as the next steps for continuing its clinical development
• 505(b)(2) path of approval for candidates leveraging ISM® technology
Rapid and sustained Letrozole plasma levels
Expected Value Proposition:
Rapid & Sustained Estrogen Suppression Targeting a LONG ACTING Injection 100
• Preliminary results suggest that sustained long-term hormone suppression
80
therapy (HT) may obtain a superior clinical outcome in breast cancer
Letrozole Plasma Levels
Superior compared to an oral daily dosage treatment
Efficacy • Early discontinuation and non-adherence to HT are common and associated
60
(ng/mL)
Femara
with increased mortality – improved treatment compliance with Letrozole
ISM® has potential to enhance treatment 40 Letrozole ISM
• Sustained lower effective doses (compared to oral treatment) could reduce 20
Improved adverse side effects (bone mass loss, bone/joint/muscle pain, dyslipidemia)
due to lower exposure to drug
Safety 0
Profile • Better safety profile has potential to positively impact treatment duration 0 20 40 60 80 100 120
adherence Time (days)
33
Source: Company information.Letrozole ISM®: Potentially unique LAI in
hormone-dependent breast cancer market
Attractive Potential Market Potential market for Letrozole-ISM®
● Hormone receptor-positive (HR+) breast cancer market has a relatively
high lifetime prevalence and is expected to grow significantly over the
next ten years
● Revenues across the US, Japan, and five major EU markets expected to High treatment posology switching rate
expected
grow at 16.7% from 2015-20241 No presence of LAIs for this
Strict compliance needed to avoid relapses during at least 3 year disease: future potential
● Focused group of
treatment target market could be a Letrozole and Anastrozole patients
high-rate conversion from
● LAIs2 have no presence in this market but the easier posology system will
oral market High % of dynamic market of new
become the gold standard for treatment given improved adherence and
treatments is expected to be targeted
effectiveness
Total daily units
MAT Q3-19 Letrozole and Anastrozole World Market (oral daily units)3 All new treatments under development are
on top of hormone suppression
42%
No substitution of
aromatase inhibitors is Risk-benefit profile of hormone inhibitors is
US very high
expected
Europe
ROVI is the only company researching in
RoW
26%
this hormone-dependent breast cancer
32%
market
Largest letrozole and Second largest letrozole and
anastrozole oral market anastrozole oral market
1. Data Monitor 2017.
34
2. LAIs stands for Long Acting Injectables.
3. IQUIA-Midas MAT Q3 2019: EUR is Total Europe; RoW Rest of the Word excludes Europe and USA.Letrozole ISM®: Approach to ROVI’s Potential Market
Potential market for Letrozole-ISM® Approach to Prostate Cancer LAls Market
• There are 1.074 m daily units of these two molecules, that converted • Breast cancer can be compared to prostate cancer, as it has a similar
to yearly treatment, bring 2.9 m potential yearly treatments for LAIs1 behaviour in prevalence
market
• Around 3 years of strict compliance are needed to avoid relapses
• Exemestane is a third molecule to treat this disease with oral
posology, so it is another candidate to switch to LAI • Goserelin, Histrelin, Degarelix, Leuprorelin and Triptorelin are the
molecules to treat prostate cancer
• There are 123 m daily units of exemestane, that converted to yearly
treatment bring 338,239 treatments for LAI market • LAIs1 have a strong presence in this market and have become the
gold standard for treatments (89% market share in value)
• ROVI aims to reach a significant portion of the market
LAIs represent 89% of total prostate cancer market in value in EU and US
MAT Q3-19 Market Share of LAIs in US & EU2
1.074 m Prostate Cancer Market
2.9 m
daily units of 365 orals Yearly treatments
Anastrozole and per year 89%
Worldwide
Letrozole Worldwide
123m $2.5Bn US
338,239
daily units of 365 orals Yearly treatments EU
Exemestane per year
Worldwide Top 5
Worldwide
11%
LAIs and Orals in value
1. LAIs stands for Long Acting Injectables.
35
2. IQVIA-Midas MAT Q3 2019: EU is Total Europe.FINANCIAL RESULTS Javier López-Belmonte Vicepresident and Chief Financial Officer
Sound Financial Policy Supported by Strong Track Record
Specialty Pharma ++ ISM® Platform = ROVI Group
Total Revenues 1 R&D Revenues 5 Total Revenues 1&5
€m 276 304 382 421
92
€m
€m 277 305 382 422
66
61 55
316 330
1,3 1,1 0,5 0,6
215 249
2017A 2018A 2019A 2020A
2017A 2018A 2019A 2020A 2017A 2018A 2019A 2020A
Adjusted EBITDA 2 Net R&D Expenses 6 Adjusted EBITDA 2 EBITDA Pre-
R&D
Margin 3
€m
20.6% 20.1% 23.5% 28.0% Margin 3 22.4%
€m 16.0%
2017A 2018A 2019A 2020A 9.7%
90 117 10.9% 118
57 61 €m
63
90
58 61 94
(24) 30 30
(28) (32) (29)
2017A 2018A 2019A 2020A
2017A 2018A 2019A 2020A
Capex ISM Capex Capex
Cash 66.9% 58.4% 58.7% 74.4%
€m Cash 33.4% 10.6% 33.4% 57.9%
Conver.4
37 30 9,7 Conver.4
€m
19 25 3,5
1,1 1,1 €m 41 40
20 26
2017A 2018A 2019A 2020A
2017A 2018A 2019A 2020A
Total Pharma CMO
Products 2017A 2018A 2019A 2020A
Proven track record of Specialty Pharma business
4. Cash Conversion calculated as (Adjusted EBITDA – Capex)/Adjusted EBITDA.
1. Toll Manufacturing total revenues are ROVI’s Sales of services. Pharma products total revenues include Sales of goods, Revenues from licenses and government grants.
5. ISM® Platform total revenues are fully comprised of government grants. 37
2. Adjusted EBITDA defined as profit for the year, before income tax, finance costs-net and depreciation and amortization.
6. Calculated as R&D revenues minus R&D expenses, which include Specialty Pharma R&D expenses of enoxaparin
3. Adjusted EBITDA margin calculated as Adjusted EBITDA divided by Operating revenues (defined as Total revenues minus grants).
biosimilar Becat®.9M 2021 results (1/2)
Specialty pharma business €m
REVENUE EBITDA EBIT
Prescription
€256.6 +18% products
463.5 (+53%) 139.5 (+100%) 123.3 (+123%)
Total
Capex Net cash €283.3m Contrast
Net profit €25.8 +17%
agents
98.9 (+111%) 22.0 (30%) 74.4 +18%
OTC &
€0.9 +78% Other
2022 operating revenue guidance: ROVI expects a mid-single-digit
growth rate for the operating revenue
Heparin franchise* €181.5 +15%
39% of operating revenue
For 2021, ROVI is upgrading again its 2021 operating revenue
guidance from the range between 35% and 40% to the 40% and 45%
LMWH €176.2 +15%
range.
Bemiparin sales Enoxaparin sales
Operating revenue €m €86.3m +13% €89.9m +17%
500 ✔Directly marketed in
Germany, UK, Italy, ✔ Launched in
Spain +3% Portugal, Spain and 28 countries.
400
€51.8m Poland
300 283,3 International ✔ Approved in 26
countries in Europe
€34.5m +32% and 24 in RoW
200
239,5 * LMWH (Bemiparin and Enoxaparin biosimilar) + other heparins
100
180,2
0
62,7 CMO business €m
9M 2020 9M 2021
Total +187%
CMO Business Specialty pharma €180.2m
389M 2021 results (2/2)
Gross profit (€m) and gross margin (%) EBITDA (€m) and EBITDA margin (%)
57,6%
58,1% 60% 150 30,1% 40%
250
EBITDA Pre-R&D1 +86%
200 +52% 100 23,1%
30%
€m
40% €158.6m
€Mn
150 139,5 20%
266,8
100 50
175,4 20% 69,7 10%
50
0 0%
0 0% 9M 2020 9M 2021
9M 2020 9M 2021
EBITDA EBITDA margin
Gross profit Gross margin
SG&A (€m) R&D (€m) Net profit (€m)
100
125 23,4%
29,8% 30%
9M 2021 19,1
100 +111%
€Mn
50 98,9
+22%
€Mn
75 20%
+20%
50 108,3 46,8
90,1 9M 2020 15,6
10%
25
0
- 0% 9M 2020 9M 2021
9M 2020 9M 2021 10 12 14 16 18 20
Net profit Pre-R&D1 +89%
SG&A SG&A/Operating revenue €m €114.1m
1 Calculated excluding R&D expenses in 9M 2021 and 9M 2020 39Capital allocation supports growth
Cash Flow from operating activities increased to €137.9Mn in 9M 2021 mainly Cash generation in 9M 2021 (€Mn)
due to:
• Increase of €70.1Mn in profit before income tax;
• Increase of €2.1Mn in the “inventories” line in 9M 2021 compared to a
decrease of €79.4Mn in 9M 2020;
• Booking of €21.5Mn under the “Proceeds from toll manufacturing services”
caption in 9M 2021 compared to the €18.1Mn euros recognized in 9M 2020;
and
• Increase of €10.7Mn in the “trade and other payables” item in 9M 2021
compared to a decrease of €5.3Mn in 9M 2020.
Debt analysis
Debt with public administration represented 15% of total debt, with 0%
Debt maturities as of Sept 30, 2021 (€Mn)
interest rate.
50 Total debt 45,6
Bank borrowings represented 63% of total debt as of 30 September 2021. They €71.9Mn
consist of a European Investment Bank loan with long maturities. 40
30
Net cash of €74.4Mn as of 30 September 2021 vs €56.1Mn as of 30 June 2021 and 20
€19.8Mn net debt as of 31 December 2020. 9,9 10,0
10 4,9
1,5
As of 30 September 2021, ROVI had a gross cash position of €146.3Mn, 0
2021 2022 2023 2024 2025 and
compared to €129.0Mn as of 30 June 2021 and €54.6Mn as of 31 December 2020. beyond
Focused on creating value
40ROVI is increasing remuneration to shareholders
Purpose and scope
To redeem own shares of ROVI (share capital reduction) while, at the same
time, increasing the remuneration of ROVI’s shareholders by raising earnings
per share.
Duration
From today, 3 November 2021, for a twelve-month period.
Maximum monetary amount
Up to 125,000,000 euros.
Maximum number of shares to be acquired
1,682,000 shares of the Company, representing approximately 3% of the
Company’s share capital
41Outlook 2022
2022 operating revenue growth rate
Mid-single-digit
The key Growth levers in 2022
Specialty Pharma CMO
Bemiparin
Spare capacity in the manufacturing
Biosimilar of Enoxaparin plants
Launches such as Neparvis® New customers to be acquired
and Volutsa®
Agreement with Moderna
Existing portfolio of specialty
pharmaceuticals
Given the uncertainties associated to the development of the Covid-19 pandemic, it is not yet
possible to make a precise assessment of the impact that the pandemic will have on 2022.
422023 long term guidance expected to be achieved in 2021
LT indicative
2018 2021
guidance 2023
Operating X2 Expected to be
€303.2Mn €588Mn - €609Mn
revenues €606.4Mn achieved in 2021
€158.6Mn in 9M 2021 X2.5 Already achieved
EBITDA pre-R&D €63.0Mn
EBITDA pre-R&D €157.5Mn in 9M 2021
Next phase of growth achieved through several key levers (Enoxaparin biosimilar, Risperidone ISM®, Letrozole-ISM®,
M&A activities, Moderna agreement)…
… underpinned by solid specialty pharma and toll manufacturing businesses
43For further information, please contact: Juan López-Belmonte Chairman and Chief Executive Officer +34 91 3756235 www.rovi.es Javier López-Belmonte Vicepresident and Chief Financial Officer +34 91 3756266 www.rovi.es Marta Campos Head of Investor Relations +34 91 2444422 mcampos@rovi.es www.rovi.es Antonio Marquina Investor Relations +34 674 315 715 amarquina@rovi.es www.rovi.es
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